TransCelerate Releases Assets for eConsent

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11/14/17

TransCelerate Biopharma Inc. has released a set of eConsent Assets as part of its eConsent Initiative.

Background:

• Clinical trials have become more complex, with longer and more detailed Consent Forms.
• Moving from paper-based Consent Forms to electronic Consent Forms (eConsent) attempts to address challenges such as 1) subject comprehension, 2) subject compliance, and 3) study retention.

Purpose:

• The eConsent Initiative has been developed to guide industry into widespread voluntary adoption of eConsent utilizing an array of assets.
• The assets are tools, templates, and guidance documents designed to direct stakeholders, sponsors or other organizations, in adopting and implementing eConsents.

Assets:

• The TransCelerate eConsent Implementation Guidance is designed to improve implementation of eConsent and includes considerations for 1) operation, 2) implementation, 3) internal / external processes, and 4) future trends.
• Site-Facing tools and templates were created for sites and sponsors to use while implementing eConsent:
  • Introduction of eConsent for Sites
  • Site FAQ Template
  • Site Survey Template
  • Patient Survey Template
• CTTI/WHO Operational Examples of eConsent contains eConsent templates from Clinical Trials Transformation Initiative (CTTI) and World Health Organization (WHO).
• eConsent Landscape Assessments include blinded and aggregated data from surveys sent to 1) Clinical Research Organizations, 2) pharmaceutical manufacturers, and 3) eConsent vendors regarding their experiences with eConsent.
  • Assessment Summary
  • Detailed Results
  • Survey Questions

Conclusion:

The newly released TransCelerate eConsent Assets contain an array of tools and guidelines designed to assist stakeholders in widespread adoption of eConsent. While developing the Assets, TransCelerate worked with Clinical Research Organizations, Ethics Committees / Institutional Review Boards, Patient Advocates, Site Advocates, and Health Authorities to address concerns and differences from various stakeholders in clinical research. Adoption and implementation of eConsent should provide a solution for complex paper consent forms and streamline clinical trials from regulatory and Ethics Committee review and approval through the informed consent process.

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-The Clinical Pathways Team